Earlier this week, the Commission published a new Regulation amending Regulation 726/2004 that governs the centralised procedure and that sets out the rules for the EMA: Regulation 2019/5. Many of the changes move and consolidate the provisions set out in other Regulations into Regulation 726/2004 on the centralised procedure (known as the Regulation on the Centralised Procedure). We are preparing a more detailed advisory of the implications of the new Regulation, but some headline points are as follows:
Arnold & Porter’s Future Pharma Forum invites you to a complimentary regulatory seminar aimed at junior lawyers and new joiners in the UK/EU life sciences industry. We will provide a comprehensive introduction to key EU regulatory law topics from an in-house practitioner’s perspective and touch on the implications of Brexit.
- Overview of the EU pharmaceutical law framework
- Clinical trials, unlicensed supply and compassionate use
- Obtaining marketing authorisations
- Incentives: regulatory data protection, marketing protection, orphan market exclusivity and paediatric rewards
- Advertising and promotion of medicinal products
- Pricing and reimbursement in the UK
- Supply chains
Who is it relevant for?
The Future Pharma Forum is a group established to provide training and networking opportunities for junior and mid-level lawyers in the life sciences industry. We conduct seminars and events aimed at junior and mid-level lawyers up to around 8 years PQE. There are no formal entry or membership requirements— please feel free to pass this to colleagues who might be interested in attending.
On 12 November 2018 the EU Commission announced that its rapid alert system formerly known as ‘RAPEX’ is being updated and rebranded as ‘Safety Gate’. Aside from the rebranding, the main new features of the Safety Gate platform are that it is more accessible to consumers, being now available in 25 languages, and it is capable of being shared by consumers via social media.
With certain exceptions, this online product safety database covers dangerous non-food products. It includes cosmetic products, but not medicines or medical devices. It is populated by alerts of potentially serious risks posed by such products. In line with applicable EU legislation, economic operators are required to notify risks presented by products that they have placed on the market in the EU to the competent national authorities in the Member States in which the affected products have been sold. The legislation requiring such notification is the General Product Safety Directive, or sector-specific legislation with similar effect, such as the legislation applicable to toys and electrical goods, as implemented in each Member State. The legislation also obliges operators to take corrective actions, such as product recall, if appropriate.
Publication of clinical trial data and results continues to be a hot topic in the EU. A recent BMJ article investigated the level of compliance with the European Commission’s requirement that the results of all trials are published within 12 months of completion. The Commission guidance expands on the obligations in the Clinical Trials Directive, and states that for all trials (paediatric and non-paediatric), result-related information should be supplied and made public within 12 months of the completion of the trial (not after grant of the marketing authorisation), including a summary of the results and conclusions.
The retrospective cohort study found that despite the Commission guidance, of the 7,274 trials where results were due, only 49.5% reported results, although trials with a commercial sponsor were substantially more likely to post results than those with a non-commercial sponsor (68.1% compared to 11.0%).
Earlier this month, the European Commission published a “rolling plan” for the implementation of the new Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). As we mentioned in our blog from last year, CAMD’s (Competent Authorities for Medical Devices) Implementation Taskforce published a high-level MDR/IVDR roadmap setting out how the Regulations will be implemented, and the order in which key guidance and clarification will be developed. Now, the Commission has published the rolling plan, which contains a list of the essential implementing acts and actions that need to be introduced, as well as providing information on expected timelines and the current state-of-play.
The next Future Pharma Forum will be on 27 September: Implications of Recent EU and UK Court Decisions in the Pharmaceutical Sector
Emily MacKenzie, Barrister at Brick Court Chambers, will join us to recap on how challenges to pharmaceutical decisions may be brought to the European and domestic courts. Emily will provide a summary of recent European Court and English Court decisions in the pharmaceutical area and we will explore the implications for pharmaceutical companies.
- How to bring challenges to the European Court
- The interplay of domestic proceedings
- Summary of recent European Court decisions, including:
- Shire on orphan market exclusivity and;
- Astellas on the role of the Concerned Member State
- Summary of recent English Court decisions, including Napp on the Article 10(3) hybrid-abridged procedure
- Changes in the Notice to Applicants regarding RDP, including the “reverse combination” principle
- The implications for pharmaceutical companies
Last month, the oral hearing before the Court of Justice of the European Union took place in Case C-557/16 relating to the role of the Concerned Member States (CMS) in the Decentralised Procedure (DCP). During the DCP, the Reference Member State (RMS) has primary responsibility for preparing the assessment report on the medicinal product, and CMSs can raise questions or objections on the grounds of a potential serious risk to public health. This case, a referral from the Finnish Court, asks whether, and if so how, administrative and legal questions, such as the length of the regulatory data protection period, should be resolved in the CMSs, considering that national marketing authorisations (MA) are granted at the end of the DCP.
The hearing highlighted that the Member States and Commission do not agree as to the interpretation of the legislation and case law, and there is a real dispute for the Court to answer. The Advocate General has said he will deliver his opinion on 30 November.